A Study of Revlimid for Treatment of Non-hodgkin's Lymphoma - Full Text View

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00413036

Purpose

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin's	Drug: lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) In Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

response rate [ Time Frame: every 2 months from the start of study medication until treatement discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reported side effects [ Time Frame: First dose of medication until 30 days after the last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental	Drug: lenalidomide once daily capsule dosing Drug: lenalidomide once daily capsule

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion criteria

Biopsy proven aggressive non-hodgkin's lymphoma
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
Relapsed or refractory to previous therapy for lymphoma
At least one prior combination chemotherapy regime
Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
ECOG performance score of 0,1 or 2
Willing to follow the pregnancy precautions

Key Exclusion criteria

Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- Platelet count < 60,000/mm3 (60 x 109/L).
- Calculated creatinine clearance of <50mL/min
- Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
History of active CNS lymphoma within the previous 6 months
History of other malignancies within the past year
Positive HIV or active Hepatitis B or C

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413036

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Locations

United States, Alabama
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Access Clinical Research
Rancho Mirage, California, United States, 92270
Kaiser Permanente Medical Group
San Diego, California, United States, 92120
United States, Florida
Hematology Oncology Associates of Central Brevard
Rockledge, Florida, United States, 32955
Pasco Hernando Oncology Associates
Brooksville, Florida, United States, 34613
Sylvester Cancer Center/ Univeristy of Miami
Miami, Florida, United States, 33136
United States, Indiana
Cancer Care Center, Inc.
New Albany, Indiana, United States, 47150
United States, Louisiana
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States, 70809
United States, Michigan
Michigan Hematology and Oncology Institute
Southgate, Michigan, United States, 48195
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
United States, New York
Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
United States, Pennsylvania
HIllman Cancer Center -UPMC
Pittsburg, Pennsylvania, United States, 15232
United States, South Carolina
Palmetto Hematology Oncology
Spartanburg, South Carolina, United States, 29303
Canada, Ontario
London Health Science Center
London, Ontario, Canada
Canada, Saskatchewan
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada
Germany
Research Site
Homburg, Germany
Research Site
Heidelberg, Germany
Research Site
Goettingen, Germany
Research Site
Koeln, Germany
Research Site
Berlin, Germany
Spain
Research Site
Valencia, Spain

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Annette Earvin-Haynes, DO

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation ( Celgene Corporation )
Study ID Numbers:	CC-5013-NHL-003
Study First Received:	December 18, 2006
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00413036 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Celgene
Revlimid
CC-5013
Non-hodgkin's lymphoma

Lenalidomide
CC5013
NHL

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Thalidomide
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Lenalidomide
Angiogenesis Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Anti-Bacterial Agents
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Leprostatic Agents

ClinicalTrials.gov processed this record on November 27, 2009